Various shapeable catheters have been known in the prior art. In some instances, a malleable element (e.g., a stylet or wire) is inserted into the lumen of a flexible catheter. The malleable element is either pre-shaped prior to insertion, or it is bent to a desired shape after it has been inserted into the catheter. In either event, the malleable element imparts a desired shape to the flexible catheter. In either instances, all or part of the catheter is formed of a malleable material that can be plastically deformed to a desired shape prior to or after insertion into a patient's body.
For example, U.S. Pat. No. 4,834,709 (Banning, et al.) describes a catheter and stylet assembly which includes a silicone rubber catheter and a malleable stylet. The stylet is formed of malleable metal covered by a plastic cover. The stylet is inserted into the catheter to permit the catheter to be manually shaped into a desired form before insertion into the patient. The stylet is removable from the catheter after the catheter has been inserted into the patient's body.
U.S. Pat. No. 5,720,719 (Edwards, et al.) describes an ablative catheter having a conshapeable body. The catheter's conshapeable body includes a malleable tube and a flexible tube that allow the catheter to conform to the curvature of a cavity inside a patient's body.
U.S. Pat. No. 5,749,357 (Linder) describes a malleable introducer tube that is useable to an endotracheal tube or the like. The introducer incorporates a malleable and shape-retaining tube along at least a portion of its length. In one embodiment, intermediation of the length between the sheath and the clamp is made almost entirely by a malleable tube made of a ductile metal such as aluminum. The tube may be thick-walled to reduce the volume necessary to inflate the sheath. In another embodiment, only the introducer tip may be of a malleable metal, such as copper. Significant advantages are offered by the use and inclusion of resilient, malleable portions in the introducer.
U.S. Pat. No. 5,882,346 describes a shapeable catheter and method for positioning such shapeable catheter within a body cavity. A core wire which includes a pre-shaped region is slidably received within a lumen of the catheter. The catheter includes a rigid proximal section and a flexible distal section. During use, the distal end of the catheter is inserted into a patient's vasculature and is passed into a body cavity. The pre-shaped region of the core wire is then passed into the lumen and is straightened by the rigid proximal section of the catheter. As the core wire is advanced into the more flexible distal region of the catheter, it re-assumes its predetermined shape and causes the core wire to form the distal section of the catheter into the predetermined shape. The distal section of the catheter is positioned in contact with tissue in the body cavity, and electrodes carried by the distal end are used to map and/or ablate the tissue.
U.S. Pat. No. 5,993,462 (Pomeranz, et al.) describes a shapeable catheter wherein a core wire is pre-shaped and slidably received within a lumen of the catheter. The catheter includes a rigid proximal section and a flexible distal section. A pull wire may additionally be provided to allow the user to cause deflection at a distal portion of the catheter.
U.S. Pat. No. 6,280,433 describes a tubular introducer or guide catheter for directing an implantable medical device such as a lead or catheter to a desired location within a patient's body. In one embodiment of the invention, the introducer comprises a two-lumen tube. A first lumen is configured to receive the implantable medical device that is to be introduced. A second lumen is provided to receive an insertable, elongated guiding member such as a stylet, which may be shapeable in various orientations, and which may be used to alter the configuration of the introducer. The second lumen may be provided with an internal coil or other tubular reinforcement member to prevent perforation of this lumen by the guiding member when the introducer is in the patient's body.
U.S. Pat. No. 6,979,979 (Lawrence, et al.) describes a malleable cannula. A reinforcement member extends along a lumen of the cannula, such reinforcement member having an interior side facing the lumen and an exterior side facing away from the lumen. A malleable member extends along a portion of the exterior side of the reinforcement member. The malleable member may be constructed of a tube with a wire slidably received within the tube and may include an anchor.
U.S. patent application Ser. No. 11/037,548, now U.S. Pat. No. 7,462,175, issued on Dec. 9, 2008, of which this is a continuation-in-part, describes malleable guide catheters that are useable to facilitate transnasal insertion of other devices (e.g., guidewires, balloon catheters, lavage catheters, etc.) into paranasal sinuses or other locations within the ear, nose or throat of a patient. Additionally, a system of transnasal guide catheters having malleable proximal shafts and pre-set distal curves of 0°, 30°, 70°, 90° and 110° are available commercially (Relieva® Sinus Guide Catheters, Acclarent, Inc., Menlo Park, Calif.).
There remains a need for further development of new guide catheters that may be pre-shaped prior to insertion into a patient's body and their methods of manufacture and use for transnasal and/or other applications.